Company
United StatesBiomat USA Inc, Salem, OR – FDA Inspections
Inspection records and compliance data for Biomat USA Inc in Salem, Oregon. 6 FDA inspections on record, 1 Form 483, last inspected January 30, 2020.
Company Profile
This profile covers Biomat USA Inc based in Salem, Oregon, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected February 11, 2010. Last inspected January 30, 2020.
Most cited issue areas
- Equipment calibration frequency1 inspection
- Establish, maintain and follow manufacturing SOPs1 inspection
- Prevention of contamination1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 30, 2020 | NAI | Biologics · Blood and Blood Products | 1118882 |
| October 5, 2017 | VAI | Biologics · Blood and Blood Products | 1027767 |
| June 17, 2015 | NAI | Biologics · Blood and Blood Products | 930472 |
| September 19, 2013 | NAI | Biologics · Blood and Blood Products | 849552 |
| August 16, 2012 | VAI | Biologics · Blood and Blood Products | 794880 |
| February 11, 2010 | NAI | Biologics · Blood and Blood Products | 655320 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Biomat USA Inc
FEI Number
3023457
Address
351 Belmont St NE, Salem, Oregon 97301, United States
Country
United States
ID: 767d7e84-d090-47ba-b786-6824e179856d